List of Medicinal Products Subject to the Simplified Registration Procedure has been Expanded

According to the information placed on the Ukrainian government portal, the government adopted the Resolution No. 558 dated 08.08.2016 “On Amendments To The Procedure For State Registration (Re-Registration) Of Medicinal Products” in order to unify the legal regulation of the state registration of medicinal products. The proposed changes are a reflection of innovations aimed at expanding the list of medicinal products subject to the simplified state registration procedure that were previously made by amending Article 9 of the Law of Ukraine “On Medicinal Products”.

Specifically, after making such amendments, medicinal products registered by a competent authority of the USA, Switzerland, Japan, Australia, Canada, as well as under the centralized procedure by the competent authority of the European Union for use in the territory of such states or member states of the European Union, have also become subject to the simplified procedure registration.

The simplified procedure for such medicinal products envisages that:

• only materials of quality control methods for medicinal products; materials of registration dossier; a sample of packaging and labeling of the medicinal product; a patient information leaflets; a document confirming payment of the registration fee are required to be submitted in addition to an application for registration;
• those materials shall be reviewed within 10 business days;
• the materials of the registration dossier, which were submitted to the regulatory body that registered the medicinal product, should not be subject to the expert examination during the review of registration materials;
• a possibility to submit, instead of a certified copy of document confirming compliance of the manufacturing conditions of the medicinal product, submitted for registration, with requirements for manufacturing medicinal products in Ukraine, a manufacturer’s written undertaking to manufacture the relevant medicinal product for the supply to Ukraine on the same manufacturing facilities used for producing medicinal products intended for the use in the USA, Switzerland, Japan, Australia, Canada or member states of the European Union.
• the grounds for denial of state registration serve the submission of incomplete package of specified documents, the detection of false or incomplete information in these documents, an incompliance of the name of the manufacturer of the medicinal product, its business address and the address of its manufacturing facilities specified in the application for state registration of the medicinal product, to the information, based on which the competent authority of the United States, Switzerland, Japan, Australia, Canada or the European Union registered the medicinal product.

Please note that the information regarding the adoption of the Resolution was placed on the Ukrainian government portal, but the Resolution has not become effective and corresponding changes have not yet been applied to the current Procedure for State Registration (Re-Registration) of Medicinal Products.